"MDMA is pleased that CMS removed
the pivotal study and superiority study design coverage requirements from the
new IDE study approval process. We remain concerned, however, that a
centralized review process may not be more efficient than the current one, and
that the new coverage requirements could discourage Medicare beneficiaries from
participating in IDE studies. We look forward to working with CMS to support
continued access and reimbursement for IDE studies.

"In addition, MDMA is pleased that
CMS is taking a careful approach to developing comprehensive APCs for
device-dependent procedures and that they will continue to evaluate the
concept before implementing changes in 2015. While we also remain
concerned that CMS's decision to expand packaging to five more categories of
items and services could discourage appropriate use of innovative technologies
and lead to inaccurate payment rates, we will continue to work closely with the
agency to address these challenges.”